NCT02164656

Brief Summary

The Mindfulness Training for Smokers Online Feasibility Study is a pilot study designed to test Mindfulness Training for Smokers in an Internet format with phone counseling.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 12, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 16, 2014

Completed
Last Updated

October 12, 2015

Status Verified

October 1, 2015

Enrollment Period

2 years

First QC Date

June 12, 2014

Last Update Submit

October 9, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Biochemical Abstinence Testing

    Carbon Monoxide Breath Test (CO): CO is expired in detectable levels for up to 48 hours after smoking and can provide verification of tobacco use or abstinence. CO breath test is provided via a calibrated CO breath monitor. Per standard CTRI protocol, a cut-off value of less than 7 ppm will be employed to verify abstinence. Breath testing will be conducted at baseline, at 4 weeks post-quit and at 24 weeks post-quit.

    4 and 24 week post quit attempt

Secondary Outcomes (5)

  • Five Factor Mindfulness Questionnaire

    baseline, 4 and 24 months post quit

  • Depression, Anxiety and Stress Scale

    0, 4 and 24 months

  • Experiential Avoidance Scale

    0, 4, 24 months

  • Perceived Stress Scale

    0, 4, 24 months

  • MTS Online Course Evaluation

    4 months post quit

Study Arms (1)

mindfulness training

EXPERIMENTAL

8 week course in mindfulness for smokers

Behavioral: mindfulness for smokers

Interventions

mindfulness training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: 18 years or over
  • Participants must express "high" motivation to quit smoking
  • Participants must smoke 5 or more cigarettes per day

You may not qualify if:

  • Self report of alcohol use of 4 drinks or more a night on 4 or more nights per week.
  • Self report of using chewing tobacco, snuff or cigars in the last week
  • Severe depression or suicidality as assessed via the Patient Health Questionnaire (see section below for details)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin School of Medicine

Madison, Wisconsin, 53711, United States

Location

Related Publications (1)

  • Davis JM, Manley AR, Goldberg SB, Stankevitz KA, Smith SS. Mindfulness training for smokers via web-based video instruction with phone support: a prospective observational study. BMC Complement Altern Med. 2015 Mar 29;15:95. doi: 10.1186/s12906-015-0618-3.

MeSH Terms

Conditions

Cigarette Smoking

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Tobacco SmokingSmokingBehaviorTobacco Use

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2014

First Posted

June 16, 2014

Study Start

April 1, 2011

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

October 12, 2015

Record last verified: 2015-10

Locations